BS Life Sciences Vacancies at Catalent | Apply
Catalent, a global leader in drug development and manufacturing, is hiring a Validation Specialist at its Winchester, Kentucky, site. This on-site role offers an exciting opportunity to support process and cleaning validation activities for commercialized drug products and APIs. If you are looking to grow your career in the pharmaceutical industry with a company committed to patient safety, innovation, and quality, this position could be your next step.
- Job Position:ย Validation Specialist
- Location: Winchester, Kentucky, United States, 40391
- Job ID: 0090953
About the Company
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO). With over 40 international sites and thousands of scientists and technicians, Catalent delivers end-to-end solutions in product development, manufacturing, and supply. Each year, Catalent accelerates over 100 new product launches and supplies billions of doses of life-saving treatments worldwide. Its Winchester, Kentucky, facility is the flagship U.S. site for large-scale oral dose manufacturing, offering integrated analytical and development services with decades of expertise.
BS Graduates Job Description
As a Validation Specialist at Catalent, you will oversee process and cleaning validation activities for commercialized drug products and APIs. This role involves drafting and approving validation documentation, executing protocols, supporting audits, and collaborating across departments to ensure compliance with regulatory and manufacturing standards.
Key Responsibilities
- Draft, review, and approve protocols, reports, and validation documents.
- Execute approved validation protocols and coordinate with engineering, maintenance, and production teams.
- Support site Annual Product Reviews and NPIx gate reviews.
- Participate in customer audits, addressing observations and corrective actions.
- Assist in investigations of deviations, change controls, and CAPAs.
- Collaborate with customers via meetings, teleconferences, and audit responses.
- Ensure compliance with validation SOPs, guidelines, and site policies.
BS Graduates Job – Educational Qualifications
Associateโs degree in life sciences (Pharmaceuticals, Biology, or related field)
Experience and Skills
- 2 years of experience in pharma, biotech, or medical devices (Bachelorโs preferred).
- Experience in authoring, reviewing, and approving validation deliverables.
- Knowledge of cGMP regulations, validation SOPs, and site policies.
- Strong computer skills (Microsoft Word, Excel, PowerPoint, TrackWise, EDMS).
- Excellent scientific writing and documentation skills.
- Ability to sit for extended periods, perform light lifting (up to 35 lbs), and support operational needs.
Keywords: Catalent, Validation Specialist, Pharmaceutical, Biotechnology, Manufacturing, Quality, Compliance, Patient Safety, BS Life Sciences Vacancies at Catalent | Apply
